Urinary incontinence (UI) is a serious medical condition that affects both men and women. Prevalence rates for women in the US range from 25-55%, with moderate and severe cases affecting 10-20% of all women. The disorder is characterized by involuntary leakage of urine (often excessively so) upon laughing, coughing, sneezing, etc. In addition to its impact on the quality of life, is also associated with more serious medical conditions including urinary infections, skin integrity, falls with fractures, and nursing home placement. In 2000, the total cost burden of urinary incontinence in the US was calculated to exceed $20 billion.
There are several courses of treatment for urinary incontinence, including lifestyle changes (dietary changes, weight loss), behavioral/physical therapy (bladder training, pelvic muscle exercises, pessary use), pharmaceutical therapy (duloxetine), and surgery (urethral sling procedures or bulking agent injection). Given the high medical risks and expense associated with surgery and the limited efficacy of pharmaceutical therapy, lifestyle and behavioral therapies are typically recommended as the first line of treatment for treatment of UI. Pelvic muscle exercises (a.k.a. “Kegels”) in particular, have been clinically shown since the 1940s to reduce the symptoms of UI, and are recommended as an initial step toward UI management.
In addition to UI, pelvic muscle exercises are a clinically proven treatment for a variety of other medical conditions including (but not limited to) sexual dysfunction/dissatisfaction, fecal incontinence, vaginal prolapse, and pelvic pain. A non-exhaustive table of clinically studied conditions that are treatable with pelvic floor muscle exercises is shown in TABLE 1. Vaginal childbirth, in particular, is a traumatic event that can cause a stretched pelvic floor (muscles and ligaments), vagina, and surrounding nerves. Some women experience this change in anatomy from vaginal childbirth as the feeling of a “looser” or “roomier” vagina, contributing to a reduction in sexual satisfaction and self-esteem, which can ultimately lead to sexual dysfunction. Physicians and sexual therapists often recommend pelvic floor muscle exercises to treat this condition.
Pelvic muscle exercises are also used to diagnose the conditions described in TABLE 1; professionals (including physicians and physical therapists) often measure pelvic muscle strength as part of the diagnosis of a condition, and/or track progress of that condition over time. Pelvic muscle strength, when measured for this purpose, is often quantified using the Oxford Scale for Muscle Strength, described in TABLE 2.
Pelvic floor muscle exercises comprise contraction and relaxation of the pelvic floor muscles, which are responsible for controlling the flow of urine (among other purposes). A typical course of treatment of pelvic floor muscle exercises for urinary incontinence is a set of ten contractions, two to three times a day, four to seven days a week, for up to 20 weeks. Once the initial course of treatment is complete, the muscles must be maintained through a maintenance regime (e.g., perform the exercises as in treatment but at lower frequency). While most patients are able to accurately follow such a regimen either through self-education or the guidance of a physical therapist, many seek extra guidance, particularly when they are performing the exercises on their own. Specifically, many seek assistance in identifying when a muscle contraction is performed, how many have been performed, and whether each exercise or each set of exercises has been performed correctly. This last point—about performing the exercises correctly (which includes exercising with the appropriate intensity and with the appropriate form)—may be important, as up to 75% of women (and men) perform the exercises incorrectly. For example, many patients incorrectly perform what is called a Valsalva maneuver (the action of attempting to exhale with the nostrils and mouth, or the glottis, closed, hence increasing pressure in the chest and abdomen), when actually attempting to perform a pelvic floor muscle exercise. Performing the incorrect exercise when attempting to perform a pelvic floor muscle exercise can, in fact, be damaging to the tissues, and exacerbate many of the conditions described in TABLE 1.
Given the challenges associated with the diagnosis and treatment of pelvic muscle-related medical conditions described herein, there is need to:                1. Diagnose pelvic-muscle-related medical conditions better        2. Instruct a patient how to perform pelvic exercises with the correct intensity and with the correct form        3. Help a patient monitor whether he or she is performing an exercise with the correct intensity and with the correct form        4. Track/record a patient's progress through pelvic muscle floor exercises over time        5. Monitor increases in the patient's pelvic muscle strength over time        6. Motivate the patient to maintain/comply/adhere to their exercise regimen for its entire duration        
Certain embodiments described in this application include a device that provides such diagnosis, instruction, feedback, tracking over time, monitoring of muscle strength, and motivation to maintain a correct regimen for pelvic muscle exercises.